BENZAC*GEL 40G 5%

Benzac 5% Gel
Benzac 10% Gel
Benzoyl peroxide

What it is and what it is used for
Benzac contains the active ingredient benzoyl peroxide and belongs to a category of medicines used for the topical treatment of acne.
Benzac disinfects the skin; it also acts in the presence of bacteria that cause acne.

What you need to know before taking the medicine
Do not use Benzac:
- If you are allergic to benzoyl peroxide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Benzac.

Benzac is for external use only.
• Avoid contact with eyes, mouth, nostrils, and other mucous membranes. If the medicine gets into your eye, wash thoroughly with water.
• Do not apply the product to skin with superficial lesions (abrasions) or irritated skin.
• Avoid exposure to ultraviolet rays (tanning lamps) and sun during product application.
• In case of severe irritation, consult your doctor who will advise you to use Benzac less frequently, to temporarily interrupt or discontinue the use of the medicine.
• Benzoyl peroxide can cause swelling and blisters on the skin; stop using the medicine and consult your doctor if any of these symptoms occur.
• You should use caution when applying the medicine to the neck and other sensitive areas.
You may experience a slight burning sensation at the first application and, within a few days, slight redness and skin peeling may occur.
During the first weeks of treatment, most patients experience a sudden increase in peeling. This is not dangerous and normally regresses within one or two days if treatment is temporarily interrupted.

The use, especially prolonged use, of products for cutaneous use can lead to sensitisation. If this occurs, stop treatment immediately and consult your doctor to obtain appropriate therapy.
The oxidising action of the gel can discolour dyed hair and coloured clothing.

Children and adolescents
No data on efficacy and safety in children under 12 years of age are available.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adverse reactions from clinical studies are all related to skin disorders. They are reversible if the frequency of treatment is reduced or discontinued.

Very common side effects (may affect more than 1 in 10 people):
- Erythema (skin redness);
- Skin peeling (shedding of dead skin cells);
- Burning sensation on the skin;
- Dry skin.

Common side effects (may affect up to 1 in 10 people):
- Skin irritation (irritant contact dermatitis from the product);
- Itching;
- Skin pain (pain, stinging pain).

Uncommon side effects (may affect up to 1 in 100 people):
- Allergic contact dermatitis from the product.

Side effects with unknown frequency (frequency cannot be estimated from the available data):
- Swelling of the face and allergic reactions including hypersensitivity where the medicine is applied and a severe, rapidly occurring allergic reaction (anaphylaxis).

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.